-
1
-
-
84888391581
-
Developing oncology biosimilars: an essential approach for the future
-
[1] Abraham, J., Developing oncology biosimilars: an essential approach for the future. Semin Oncol 40:Suppl. 1 (2013), S5–S24.
-
(2013)
Semin Oncol
, vol.40
, pp. S5-S24
-
-
Abraham, J.1
-
2
-
-
84884910025
-
Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases
-
[2] Rinaudo-Gaujous, M., Paul, S., Tedesco, E.D., Genin, C., Roblin, X., Peyrin-Biroulet, L., Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases. Aliment Pharmacol Ther 38 (2013), 914–924.
-
(2013)
Aliment Pharmacol Ther
, vol.38
, pp. 914-924
-
-
Rinaudo-Gaujous, M.1
Paul, S.2
Tedesco, E.D.3
Genin, C.4
Roblin, X.5
Peyrin-Biroulet, L.6
-
3
-
-
84962736671
-
Saving money in the European healthcare systems with biosimilars
-
[3] Haustein, R., Millas, C., Höer, A., Häussler, B., Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J 1 (2012), 120–126.
-
(2012)
Generics Biosimilars Initiat J
, vol.1
, pp. 120-126
-
-
Haustein, R.1
Millas, C.2
Höer, A.3
Häussler, B.4
-
4
-
-
84932169735
-
The cost savings potential of biosimilar drugs in the United States
-
accessed 07.01.16
-
[4] Rand corporation, The cost savings potential of biosimilar drugs in the United States. 2014 http://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf accessed 07.01.16.
-
(2014)
-
-
Rand corporation1
-
5
-
-
84966283006
-
Guideline on similar biological medicinal products
-
accessed 07.01.16
-
[5] EMA, Guideline on similar biological medicinal products. 2014 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf accessed 07.01.16.
-
(2014)
-
-
EMA1
-
6
-
-
84959189652
-
Biosimilars: additional questions and answers regarding implementation of the biologics price competition and innovation act of 2009
-
(issued jointly by CDER and CBER, May 2015) accessed 07.01.16
-
[6] FDA, Biosimilars: additional questions and answers regarding implementation of the biologics price competition and innovation act of 2009. 2015 (issued jointly by CDER and CBER, May 2015) http://www.fda.gov/downloads/Drugs/Guidances/UCM273001.pdf accessed 07.01.16.
-
(2015)
-
-
FDA1
-
7
-
-
78049362302
-
Guidelines on evaluation of similar biotherapeutic products (SBPs)
-
accessed 07.01.16
-
[7] WHO, Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009 http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf accessed 07.01.16.
-
(2009)
-
-
WHO1
-
8
-
-
84990881055
-
Interchangeability (switching and alternating) of biosimilars
-
accessed 22.03.16
-
[8] GABI, Interchangeability (switching and alternating) of biosimilars. 2011 http://gabionline.net/Biosimilars/Research/Interchangeability-switching-and-alternating-of-biosimilars accessed 22.03.16.
-
(2011)
-
-
GABI1
-
9
-
-
84872419787
-
Assessing biosimilarity and interchangeability of biosimilar products
-
[9] Chow, S.C., Assessing biosimilarity and interchangeability of biosimilar products. Stat Med 32 (2013), 316–323.
-
(2013)
Stat Med
, vol.32
, pp. 316-323
-
-
Chow, S.C.1
-
10
-
-
84937000576
-
FDA approves first biosimilar product Zarxio
-
accessed 07.01.16
-
[10] FDA, FDA approves first biosimilar product Zarxio. 2015 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648 accessed 07.01.16.
-
(2015)
-
-
FDA1
-
11
-
-
84905717145
-
Statistical and regulatory considerations in assessments of interchangeability of biological drug products
-
[11] Tóthfalusi, L., Endrényi, L., Chow, S.C., Statistical and regulatory considerations in assessments of interchangeability of biological drug products. Eur J Health Econ 15:Suppl. 1 (2014), S5–S11.
-
(2014)
Eur J Health Econ
, vol.15
, pp. S5-S11
-
-
Tóthfalusi, L.1
Endrényi, L.2
Chow, S.C.3
-
12
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
[12] Ebbers, H.C., Crow, S.A., Vulto, A.G., Schellekens, H., Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 30 (2012), 1186–1190.
-
(2012)
Nat Biotechnol
, vol.30
, pp. 1186-1190
-
-
Ebbers, H.C.1
Crow, S.A.2
Vulto, A.G.3
Schellekens, H.4
-
13
-
-
84990931389
-
Boost for biosimilar switching as Finns add their backing
-
accessed 07.01.16
-
[13] SCRIP, Boost for biosimilar switching as Finns add their backing. 2015 http://www.scripintelligence.com/policyregulation/Boost-for-biosimilar-switching-as-Finns-add-their-backing-358581 accessed 07.01.16.
-
(2015)
-
-
SCRIP1
-
14
-
-
84990931390
-
Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators
-
accessed 07.01.16
-
[14] GABI, Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators. 2015 http://www.gabionline.net/Biosimilars/General/Dutch-medicines-agency-says-biosimilars-have-no-relevant-differences-to-originators accessed 07.01.16.
-
(2015)
-
-
GABI1
-
15
-
-
84978802168
-
France to allow biosimilars substitution
-
accessed 07.01.16
-
[15] GABI, France to allow biosimilars substitution. 2014 http://gabionline.net/Policies-Legislation/France-to-allow-biosimilars-substitution accessed 07.01.16.
-
(2014)
-
-
GABI1
-
16
-
-
84990954507
-
French Biosimilar Law – No generics-style substitution policy
-
accessed 07.01.16
-
[16] EBE, French Biosimilar Law – No generics-style substitution policy. 2014 http://www.ebe-biopharma.eu/newsroom/download/54/document/ebe-bs-statement-final_24.01.2014.pdf accessed 07.01.16.
-
(2014)
-
-
EBE1
-
17
-
-
85057729694
-
Australia's PBAC recommends substitution of biosimilars
-
accessed 07.01.16
-
[17] GABI, Australia's PBAC recommends substitution of biosimilars. 2015 http://www.gabionline.net/Biosimilars/General/Australia-s-PBAC-recommends-substitution-of-biosimilars accessed 07.01.16.
-
(2015)
-
-
GABI1
-
18
-
-
84990933275
-
Biosimilars policies in Italy
-
accessed 07.01.16
-
[18] GABI, Biosimilars policies in Italy. 2012 http://www.gabionline.net/Reports/Biosimilars-policies-in-Italy accessed 07.01.16.
-
(2012)
-
-
GABI1
-
19
-
-
85013300319
-
Position of Paul-Ehrlich-Institut regarding the use of biosimilars
-
accessed 07.01.16
-
[19] PEI, Position of Paul-Ehrlich-Institut regarding the use of biosimilars. 2015 http://www.pei.de/EN/medicinal-products/antibodies-immunoglobulins-fusion-proteins/monoclonal-antibodies/biosimilars/position-pei-interchangebility-biosimilars-content.html accessed 07.01.16.
-
(2015)
-
-
PEI1
-
20
-
-
3242677099
-
Effect of a treatment strategy of tight control for rhuematoid arthritis (the TICORA study): a single-blind randomised controlled trial
-
[20] Grigor, C., Capell, H., Stirling, A., McMahon, A.D., Lock, P., Vallance, R., et al. Effect of a treatment strategy of tight control for rhuematoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 23:364 (2004), 263–269.
-
(2004)
Lancet
, vol.23
, Issue.364
, pp. 263-269
-
-
Grigor, C.1
Capell, H.2
Stirling, A.3
McMahon, A.D.4
Lock, P.5
Vallance, R.6
-
21
-
-
42949168291
-
Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial
-
[21] Goekoop-Ruiterman, Y.P., de Vries-Bouwstra, J.K., Allaart, C.F., van Zeben, D., Kerstens, P.J., Hazes, J.M., et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 52:Suppl. 2 (2005), S126–S135.
-
(2005)
Arthritis Rheum
, vol.52
, pp. S126-S135
-
-
Goekoop-Ruiterman, Y.P.1
de Vries-Bouwstra, J.K.2
Allaart, C.F.3
van Zeben, D.4
Kerstens, P.J.5
Hazes, J.M.6
-
22
-
-
84893772728
-
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update
-
[22] Smolen, J.S., Landewé, R., Breedveld, F.C., Buch, M., Burmester, G., Dougados, M., et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 73 (2014), 492–509.
-
(2014)
Ann Rheum Dis
, vol.73
, pp. 492-509
-
-
Smolen, J.S.1
Landewé, R.2
Breedveld, F.C.3
Buch, M.4
Burmester, G.5
Dougados, M.6
-
23
-
-
79953761841
-
Guidelines for the management of inflammatory bowel disease in adults
-
[23] Mowat, C., Cole, A., Windsor, A., Ahmad, T., Arnott, I., Driscoll, R., et al. Guidelines for the management of inflammatory bowel disease in adults. Gut 60 (2011), 571–607.
-
(2011)
Gut
, vol.60
, pp. 571-607
-
-
Mowat, C.1
Cole, A.2
Windsor, A.3
Ahmad, T.4
Arnott, I.5
Driscoll, R.6
-
24
-
-
84859832981
-
2012 update of the 2008 American college of rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis
-
[24] Singh, J.A., Furst, D.E., Bharat, A., Curtis, J.R., Kavanaugh, A.F., Kremer, J.M., et al. 2012 update of the 2008 American college of rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res Hob 64 (2012), 625–639.
-
(2012)
Arthritis Care Res Hob
, vol.64
, pp. 625-639
-
-
Singh, J.A.1
Furst, D.E.2
Bharat, A.3
Curtis, J.R.4
Kavanaugh, A.F.5
Kremer, J.M.6
-
25
-
-
84855161776
-
Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial
-
[25] Van Assche, G., Vermeire, S., Ballet, V., Gabriels, F., Noman, M., D'Haens, G., et al. Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial. Gut 61 (2012), 229–234.
-
(2012)
Gut
, vol.61
, pp. 229-234
-
-
Van Assche, G.1
Vermeire, S.2
Ballet, V.3
Gabriels, F.4
Noman, M.5
D'Haens, G.6
-
26
-
-
78650678574
-
Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register
-
[26] Lie, E., van der Heijde, D., Uhlig, T., Mikkelsen, K., Rødevand, E., Koldingsnes, W., et al. Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register. Ann Rheum Dis 70 (2011), 157–163.
-
(2011)
Ann Rheum Dis
, vol.70
, pp. 157-163
-
-
Lie, E.1
van der Heijde, D.2
Uhlig, T.3
Mikkelsen, K.4
Rødevand, E.5
Koldingsnes, W.6
-
27
-
-
77951548027
-
Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study
-
[27] Bartelds, G.M., Wijbrandts, C.A., Nurmohamed, M.T., Stapel, S., Lems, W.F., Aarden, L., et al. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 69 (2010), 817–821.
-
(2010)
Ann Rheum Dis
, vol.69
, pp. 817-821
-
-
Bartelds, G.M.1
Wijbrandts, C.A.2
Nurmohamed, M.T.3
Stapel, S.4
Lems, W.F.5
Aarden, L.6
-
28
-
-
78751705197
-
The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept
-
[28] Jamnitski, A., Bartelds, G.M., Nurmohamed, M.T., van Schouwenburg, P.A., van Schaardenburg, D., Stapel, S.O., et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 70 (2011), 284–288.
-
(2011)
Ann Rheum Dis
, vol.70
, pp. 284-288
-
-
Jamnitski, A.1
Bartelds, G.M.2
Nurmohamed, M.T.3
van Schouwenburg, P.A.4
van Schaardenburg, D.5
Stapel, S.O.6
-
29
-
-
80755132171
-
Outcomes of switching anti-TNF drugs in rheumatoid arthritis—a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN)
-
[29] Virkki, L.M., Valleala, H., Takakubo, Y., Vuotila, J., Relas, H., Komulainen, R., et al. Outcomes of switching anti-TNF drugs in rheumatoid arthritis—a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN). Clin Rheumatol 30 (2011), 1447–1454.
-
(2011)
Clin Rheumatol
, vol.30
, pp. 1447-1454
-
-
Virkki, L.M.1
Valleala, H.2
Takakubo, Y.3
Vuotila, J.4
Relas, H.5
Komulainen, R.6
-
30
-
-
84926645102
-
Effectiveness of TNF inhibitor switch in RA: results from the national Swedish register
-
[30] Chatzidionysiou, K., Askling, J., Eriksson, J., Kristensen, L.E., van Vollenhoven, R., ARTIS group, Effectiveness of TNF inhibitor switch in RA: results from the national Swedish register. Ann Rheum Dis 74 (2015), 890–896.
-
(2015)
Ann Rheum Dis
, vol.74
, pp. 890-896
-
-
Chatzidionysiou, K.1
Askling, J.2
Eriksson, J.3
Kristensen, L.E.4
van Vollenhoven, R.5
ARTIS group6
-
31
-
-
84885182023
-
Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study
-
[31] Fagerli, K.M., Lie, E., van der Heijde, D., Heiberg, M.S., Kalstad, S., Rødevand, E., et al. Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study. Ann Rheum Dis 72 (2013), 1840–1844.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1840-1844
-
-
Fagerli, K.M.1
Lie, E.2
van der Heijde, D.3
Heiberg, M.S.4
Kalstad, S.5
Rødevand, E.6
-
32
-
-
33846239331
-
Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study
-
[32] Hyrich, K.L., Lunt, M., Watson, K.D., Symmons, D.P., Silman, A.J., British Society for Rheumatology Biologics Register, Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum 56 (2007), 13–20.
-
(2007)
Arthritis Rheum
, vol.56
, pp. 13-20
-
-
Hyrich, K.L.1
Lunt, M.2
Watson, K.D.3
Symmons, D.P.4
Silman, A.J.5
British Society for Rheumatology Biologics Register6
-
33
-
-
84921355050
-
The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated with an anti-tumour necrosis factor
-
[33] Harrold, L.R., Reed, G.W., Kremer, J.M., Curtis, J.R., Solomon, D.H., Hochberg, M.C., et al. The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated with an anti-tumour necrosis factor. Ann Rheum Dis 74 (2015), 430–436.
-
(2015)
Ann Rheum Dis
, vol.74
, pp. 430-436
-
-
Harrold, L.R.1
Reed, G.W.2
Kremer, J.M.3
Curtis, J.R.4
Solomon, D.H.5
Hochberg, M.C.6
-
34
-
-
34248545097
-
B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents
-
[34] Finckh, A., Ciurea, A., Brulhart, L., Kyburz, D., Möller, B., Dehler, S., et al. B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents. Arthritis Rheum 56 (2007), 1417–1423.
-
(2007)
Arthritis Rheum
, vol.56
, pp. 1417-1423
-
-
Finckh, A.1
Ciurea, A.2
Brulhart, L.3
Kyburz, D.4
Möller, B.5
Dehler, S.6
-
35
-
-
84867404092
-
Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR study
-
[35] Gomez-Reino, J.J., Maneiro, J.R., Ruiz, J., Roselló, R., Sanmarti, R., Romero, A.B., et al. Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR study. Ann Rheum Dis 71 (2012), 1861–1864.
-
(2012)
Ann Rheum Dis
, vol.71
, pp. 1861-1864
-
-
Gomez-Reino, J.J.1
Maneiro, J.R.2
Ruiz, J.3
Roselló, R.4
Sanmarti, R.5
Romero, A.B.6
-
36
-
-
84866773063
-
Rituximab is more effective than second anti-TNF therapy in rheumatoid arthritis patients and previous TNFα blocker failure
-
[36] Kekow, J., Mueller-Ladner, U., Schulze-Koops, H., Rituximab is more effective than second anti-TNF therapy in rheumatoid arthritis patients and previous TNFα blocker failure. Biologics 6 (2012), 191–199.
-
(2012)
Biologics
, vol.6
, pp. 191-199
-
-
Kekow, J.1
Mueller-Ladner, U.2
Schulze-Koops, H.3
-
37
-
-
80155146611
-
Effectiveness of a third tumor necrosis factor-α-blocking agent compared with rituximab after failure of 2 TNF- blocking agents in rheumatoid arthritis
-
[37] Blom, M., Kievit, W., Donders, A.R., den Broeder, A.A., Straten, V.H., Kuper, I., et al. Effectiveness of a third tumor necrosis factor-α-blocking agent compared with rituximab after failure of 2 TNF- blocking agents in rheumatoid arthritis. J Rheumatol 38 (2011), 2355–2361.
-
(2011)
J Rheumatol
, vol.38
, pp. 2355-2361
-
-
Blom, M.1
Kievit, W.2
Donders, A.R.3
den Broeder, A.A.4
Straten, V.H.5
Kuper, I.6
-
38
-
-
84926650522
-
The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituxi mab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug
-
[38] Navarro Coy, N.C., Brown, S., Bosworth, A., Davies, C.T., Emery, P., Everett, C.C., et al. The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituxi mab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. BMC Musculoskelet Disord, 15, 2014, 452.
-
(2014)
BMC Musculoskelet Disord
, vol.15
, pp. 452
-
-
Navarro Coy, N.C.1
Brown, S.2
Bosworth, A.3
Davies, C.T.4
Emery, P.5
Everett, C.C.6
-
39
-
-
84911401436
-
Biosimilars: the science of extrapolation
-
[39] Weise, M., Kurki, P., Wolff-Holz, E., Bielsky, M.C., Schneider, C.K., Biosimilars: the science of extrapolation. Blood 124 (2014), 3191–3196.
-
(2014)
Blood
, vol.124
, pp. 3191-3196
-
-
Weise, M.1
Kurki, P.2
Wolff-Holz, E.3
Bielsky, M.C.4
Schneider, C.K.5
-
40
-
-
84885599208
-
Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics
-
[40] Devlin, S.M., Bressler, B., Bernstein, C.N., Fedorak, R.N., Bitton, A., Singh, H., et al. Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol 27 (2013), 567–571.
-
(2013)
Can J Gastroenterol
, vol.27
, pp. 567-571
-
-
Devlin, S.M.1
Bressler, B.2
Bernstein, C.N.3
Fedorak, R.N.4
Bitton, A.5
Singh, H.6
-
41
-
-
84904069611
-
The challenge of indication extrapolation for infliximab biosimilars
-
[41] Feagan, B.G., Choquette, D., Ghosh, S., Gladman, D.D., Ho, V., Meibohm, B., et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals 42 (2014), 177–183.
-
(2014)
Biologicals
, vol.42
, pp. 177-183
-
-
Feagan, B.G.1
Choquette, D.2
Ghosh, S.3
Gladman, D.D.4
Ho, V.5
Meibohm, B.6
-
42
-
-
0033524159
-
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoidarthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group
-
[42] Maini, R., St Clair, E.W., Breedveld, F., Furst, D., Kalden, J., Weisman, M., et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoidarthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 354 (1999), 1932–1939.
-
(1999)
Lancet
, vol.354
, pp. 1932-1939
-
-
Maini, R.1
St Clair, E.W.2
Breedveld, F.3
Furst, D.4
Kalden, J.5
Weisman, M.6
-
43
-
-
2342486903
-
Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease
-
[43] Su, C.G., Lichtenstein, G.R., Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. Gastroenterology 125 (2003), 1544–1546.
-
(2003)
Gastroenterology
, vol.125
, pp. 1544-1546
-
-
Su, C.G.1
Lichtenstein, G.R.2
-
44
-
-
17044432625
-
Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles
-
[44] Anderson, P.J., Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles. Semin Arthritis Rheum 34:5 suppl1 (2005), 19–22.
-
(2005)
Semin Arthritis Rheum
, vol.34
, Issue.5 suppl1
, pp. 19-22
-
-
Anderson, P.J.1
-
45
-
-
33845660797
-
Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab
-
[45] Bendtzen, K., Geborek, P., Svenson, M., Larsson, L., Kapetanovic, M.C., Saxne, T., Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab. Arthritis Rheum 54 (2006), 3782–3789.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 3782-3789
-
-
Bendtzen, K.1
Geborek, P.2
Svenson, M.3
Larsson, L.4
Kapetanovic, M.C.5
Saxne, T.6
-
46
-
-
33644931095
-
Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis
-
[46] Wolbink, G.J., Vis, M., Lems, W., Voskuyl, A.E., de Groot, E., Nurmohamed, M.T., et al. Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 54 (2006), 711–715.
-
(2006)
Arthritis Rheum
, vol.54
, pp. 711-715
-
-
Wolbink, G.J.1
Vis, M.2
Lems, W.3
Voskuyl, A.E.4
de Groot, E.5
Nurmohamed, M.T.6
-
47
-
-
84883752718
-
A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
-
[47] Yoo, D.H., Hrycaj, P., Miranda, P., Ramiterre, E., Piotrowski, M., Shevchuk, S., et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 72 (2013), 1613–1620.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1613-1620
-
-
Yoo, D.H.1
Hrycaj, P.2
Miranda, P.3
Ramiterre, E.4
Piotrowski, M.5
Shevchuk, S.6
-
48
-
-
84928045942
-
Assessment report Remsima
-
accessed 07.01.16
-
[48] EMA, Assessment report Remsima., 2013 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf accessed 07.01.16.
-
(2013)
-
-
EMA1
-
49
-
-
84867307195
-
The safety of switching between therapeutic proteins
-
[49] Ebbersa, H.C., Muenzbergb, M., Schellekens, H., The safety of switching between therapeutic proteins. Expert Opin Biol Ther 12 (2012), 1473–1485.
-
(2012)
Expert Opin Biol Ther
, vol.12
, pp. 1473-1485
-
-
Ebbersa, H.C.1
Muenzbergb, M.2
Schellekens, H.3
-
50
-
-
33747628127
-
Overview of cell-based tools for pre-clinical assessment of immunogenicity of biotherapeutics
-
[50] Kropshofer, H., Singer, T., Overview of cell-based tools for pre-clinical assessment of immunogenicity of biotherapeutics. J Immunotoxicol 3 (2006), 131–136.
-
(2006)
J Immunotoxicol
, vol.3
, pp. 131-136
-
-
Kropshofer, H.1
Singer, T.2
-
51
-
-
84888022850
-
T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation
-
[51] Jawa, V., Cousens, L.P., Awwad, M., Wakshull, E., Kropshofer, H., De Groot, A.S., T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation. Clin Immunol 149 (2013), 534–555.
-
(2013)
Clin Immunol
, vol.149
, pp. 534-555
-
-
Jawa, V.1
Cousens, L.P.2
Awwad, M.3
Wakshull, E.4
Kropshofer, H.5
De Groot, A.S.6
-
52
-
-
84942262036
-
Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima
-
[Epub ahead of print]
-
[52] Ben-Horin, S., Yavzori, M., Benhar, I., Fudim, E., Picard, O., Ungar, B., et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut, 2015 [Epub ahead of print].
-
(2015)
Gut
-
-
Ben-Horin, S.1
Yavzori, M.2
Benhar, I.3
Fudim, E.4
Picard, O.5
Ungar, B.6
-
53
-
-
84897933491
-
EU's new pharmacovigilance legislation: considerations for biosimilars
-
[53] Calvo, B., EU's new pharmacovigilance legislation: considerations for biosimilars. Drug Saf 37 (2014), 125–126.
-
(2014)
Drug Saf
, vol.37
, pp. 125-126
-
-
Calvo, B.1
-
54
-
-
84857233319
-
The state of the art in the development of biosimilars
-
[54] McCamish, M., Woollett, G., The state of the art in the development of biosimilars. Clin Pharmacol Ther 91 (2012), 405–417.
-
(2012)
Clin Pharmacol Ther
, vol.91
, pp. 405-417
-
-
McCamish, M.1
Woollett, G.2
-
55
-
-
84878900689
-
Pharmacovigilance and biosimilars: considerations, needs and challenges
-
[55] Casadevall, N., Edwards, I.R., Felix, T., Graze, P.R., Litten, J.B., Strober, B.E., et al. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 13 (2013), 1039–1047.
-
(2013)
Expert Opin Biol Ther
, vol.13
, pp. 1039-1047
-
-
Casadevall, N.1
Edwards, I.R.2
Felix, T.3
Graze, P.R.4
Litten, J.B.5
Strober, B.E.6
-
56
-
-
84856710491
-
Biosimilars: impact of biologic product life cycle and european experience on the regulatory trajectory in the United States
-
[56] Ahmed, I., Kaspar, B., Sharma, U., Biosimilars: impact of biologic product life cycle and european experience on the regulatory trajectory in the United States. Clin Ther 34 (2012), 400–419.
-
(2012)
Clin Ther
, vol.34
, pp. 400-419
-
-
Ahmed, I.1
Kaspar, B.2
Sharma, U.3
-
57
-
-
84881122457
-
Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance databases
-
[57] Vermeer, N.S., Straus, S.M., Mantel-Teeuwisse, A.K., Domergue, F., Egberts, T.C., Leufkens, H.G., et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance databases. Drug Saf 36 (2013), 617–625.
-
(2013)
Drug Saf
, vol.36
, pp. 617-625
-
-
Vermeer, N.S.1
Straus, S.M.2
Mantel-Teeuwisse, A.K.3
Domergue, F.4
Egberts, T.C.5
Leufkens, H.G.6
-
58
-
-
84918518708
-
Switching from originator to Biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden
-
[58] Flodmark, C.E., Lilja, K., Woehling, H., Järvholm, K., Switching from originator to Biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden. Biol Ther 3 (2013), 35–43.
-
(2013)
Biol Ther
, vol.3
, pp. 35-43
-
-
Flodmark, C.E.1
Lilja, K.2
Woehling, H.3
Järvholm, K.4
-
59
-
-
79958217024
-
First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor
-
[59] Lefrère, F., Brignier, A.C., Elie, C., Ribeil, J.A., Bernimoulin, M., Aoun, C., et al. First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor. Adv Ther 28 (2011), 304–310.
-
(2011)
Adv Ther
, vol.28
, pp. 304-310
-
-
Lefrère, F.1
Brignier, A.C.2
Elie, C.3
Ribeil, J.A.4
Bernimoulin, M.5
Aoun, C.6
-
60
-
-
84862163850
-
Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients
-
[60] Ianotto, J.C., Tempescul, A., Yan, X., Delepine, P., Le Calloch, R., Hardy, E., et al. Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients. Bone Marrow Transpl 47 (2012), 874–876.
-
(2012)
Bone Marrow Transpl
, vol.47
, pp. 874-876
-
-
Ianotto, J.C.1
Tempescul, A.2
Yan, X.3
Delepine, P.4
Le Calloch, R.5
Hardy, E.6
-
61
-
-
84879080850
-
Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment
-
[61] Publicover, A., Richardson, D.S., Davies, A., Hill, K.S., Hurlock, C., Hutchins, D., et al. Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment. Br J Haematol 162 (2013), 107–111.
-
(2013)
Br J Haematol
, vol.162
, pp. 107-111
-
-
Publicover, A.1
Richardson, D.S.2
Davies, A.3
Hill, K.S.4
Hurlock, C.5
Hutchins, D.6
-
63
-
-
33750014056
-
Scientific discussion
-
accessed 07.01.16
-
[63] EMA, Scientific discussion. 2007 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000727/WC500020666.pdf accessed 07.01.16.
-
(2007)
-
-
EMA1
-
64
-
-
33750014056
-
Scientific discussion
-
accessed 07.01.16
-
[64] EMA, Scientific discussion. 2007 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000872/WC500054374.pdf accessed 07.01.16.
-
(2007)
-
-
EMA1
-
65
-
-
70350776252
-
Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
-
[65] Haag-Weber, M., Vetter, A., Thyroff-Friesinger, U., INJ-Study Group, Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 72 (2009), 380–390.
-
(2009)
Clin Nephrol
, vol.72
, pp. 380-390
-
-
Haag-Weber, M.1
Vetter, A.2
Thyroff-Friesinger, U.3
INJ-Study Group4
-
66
-
-
41149131276
-
Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment
-
[66] Wizemann, V., Rutkowski, B., Baldamus, C., Scigalla, P., Koytchev, R., Epoetin Zeta Study Group, Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin 24 (2008), 625–637.
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 625-637
-
-
Wizemann, V.1
Rutkowski, B.2
Baldamus, C.3
Scigalla, P.4
Koytchev, R.5
Epoetin Zeta Study Group6
-
67
-
-
84899132159
-
Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility
-
[67] Davis-Ajami, M.L., Wu, J., Downton, K., Ludeman, E., Noxon, V., Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility. Biologics 8 (2014), 155–167.
-
(2014)
Biologics
, vol.8
, pp. 155-167
-
-
Davis-Ajami, M.L.1
Wu, J.2
Downton, K.3
Ludeman, E.4
Noxon, V.5
-
68
-
-
79251633136
-
Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis
-
[68] Więcek, A., Ahmed, I., Scigalla, P., Koytchev, R., Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis. Adv Ther 27 (2010), 941–952.
-
(2010)
Adv Ther
, vol.27
, pp. 941-952
-
-
Więcek, A.1
Ahmed, I.2
Scigalla, P.3
Koytchev, R.4
-
69
-
-
84876736657
-
A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia
-
[69] Hörbrand, F., Bramlage, P., Fischaleck, J., Hasford, J., Brunkhorst, R., A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol 69 (2013), 929–936.
-
(2013)
Eur J Clin Pharmacol
, vol.69
, pp. 929-936
-
-
Hörbrand, F.1
Bramlage, P.2
Fischaleck, J.3
Hasford, J.4
Brunkhorst, R.5
-
70
-
-
84913533583
-
Physicochemical characterization of Remsima
-
[70] Jung, S.K., Lee, K.H., Jeon, J.W., Lee, J.W., Kwon, B.O., Kim, Y.J., et al. Physicochemical characterization of Remsima. MAbs 6 (2014), 1163–1177.
-
(2014)
MAbs
, vol.6
, pp. 1163-1177
-
-
Jung, S.K.1
Lee, K.H.2
Jeon, J.W.3
Lee, J.W.4
Kwon, B.O.5
Kim, Y.J.6
-
71
-
-
84883746909
-
A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
-
[71] Park, W., Hrycaj, P., Jeka, S., Kovalenko, V., Lysenko, G., Miranda, P., et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 72 (2013), 1605–1612.
-
(2013)
Ann Rheum Dis
, vol.72
, pp. 1605-1612
-
-
Park, W.1
Hrycaj, P.2
Jeka, S.3
Kovalenko, V.4
Lysenko, G.5
Miranda, P.6
-
72
-
-
84947032856
-
Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis
-
[72] Takeuchi, T., Yamanaka, H., Tanaka, Y., Sakurai, T., Saito, K., Ohtsubo, H., et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol 25 (2015), 817–824.
-
(2015)
Mod Rheumatol
, vol.25
, pp. 817-824
-
-
Takeuchi, T.1
Yamanaka, H.2
Tanaka, Y.3
Sakurai, T.4
Saito, K.5
Ohtsubo, H.6
-
73
-
-
84942273178
-
Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13
-
(L1)
-
[73] Yoo, D.H., Prodanovic, N., Jaworski, J., Miranda, P., Ramiterre, E.B., Lanzon, A., et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum, 65, 2013, 3319 (L1).
-
(2013)
Arthritis Rheum
, vol.65
, pp. 3319
-
-
Yoo, D.H.1
Prodanovic, N.2
Jaworski, J.3
Miranda, P.4
Ramiterre, E.B.5
Lanzon, A.6
-
74
-
-
84942273177
-
Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13
-
(L15)
-
[74] Park, W., Miranda, P., Brzosko, M., Wiland, P., Gutierrez-Ureña, S., Mikazane, H., et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P13. Arthritis Rheum, 65, 2013, 3326 (L15).
-
(2013)
Arthritis Rheum
, vol.65
, pp. 3326
-
-
Park, W.1
Miranda, P.2
Brzosko, M.3
Wiland, P.4
Gutierrez-Ureña, S.5
Mikazane, H.6
-
75
-
-
84990881107
-
Efficacy and safety of switching from reference infliximab to CT-P13 compared to maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS
-
[In press]
-
[75] Brown, J., Park, D.I., Efficacy and safety of switching from reference infliximab to CT-P13 compared to maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS. Arthritis Rheum, 2016 [In press].
-
(2016)
Arthritis Rheum
-
-
Brown, J.1
Park, D.I.2
-
76
-
-
84940081554
-
Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study
-
[Epub ahead of print]
-
[76] Jung, Y.S., Park, D.I., Kim, Y.H., Lee, J.H., Seo, P.J., Cheon, J.H., et al. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study. J Gastroenterol Hepatol, 2015 [Epub ahead of print].
-
(2015)
J Gastroenterol Hepatol
-
-
Jung, Y.S.1
Park, D.I.2
Kim, Y.H.3
Lee, J.H.4
Seo, P.J.5
Cheon, J.H.6
-
77
-
-
84942325078
-
Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea
-
[77] Park, S.H., Kim, Y.H., Lee, J.H., Kwon, H.J., Lee, S.H., Park, D.I., et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 9:Suppl. 1 (2015), 35–44.
-
(2015)
Expert Rev Gastroenterol Hepatol
, vol.9
, pp. 35-44
-
-
Park, S.H.1
Kim, Y.H.2
Lee, J.H.3
Kwon, H.J.4
Lee, S.H.5
Park, D.I.6
-
78
-
-
84934294253
-
Clinical experience of the use of CT-P13, a Biosimilar to Infliximab in patients with inflammatory Bowel disease: a case series
-
[78] Kang, Y.S., Moon, H.H., Lee, S.E., Lim, Y.J., Kang, H.W., Clinical experience of the use of CT-P13, a Biosimilar to Infliximab in patients with inflammatory Bowel disease: a case series. Dig Dis Sci 60 (2015), 951–956.
-
(2015)
Dig Dis Sci
, vol.60
, pp. 951-956
-
-
Kang, Y.S.1
Moon, H.H.2
Lee, S.E.3
Lim, Y.J.4
Kang, H.W.5
-
79
-
-
84990915130
-
Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observation
-
[Epub ahead of print]
-
[79] Joanna, S., Dorota, J., Aleksandra, B., Anna, P., Agnieszka, G., Ewa, T.K., et al. Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observation. J Crohns Colitis, 2015 [Epub ahead of print].
-
(2015)
J Crohns Colitis
-
-
Joanna, S.1
Dorota, J.2
Aleksandra, B.3
Anna, P.4
Agnieszka, G.5
Ewa, T.K.6
-
80
-
-
84946601256
-
Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data
-
Dec
-
[80] Nikiphorou, E., Kautiainen, H., Hannonen, P., Asikainen, J., Kokko, A., Rannio, T., et al. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 15 (2015 Dec), 1677–1683.
-
(2015)
Expert Opin Biol Ther
, vol.15
, pp. 1677-1683
-
-
Nikiphorou, E.1
Kautiainen, H.2
Hannonen, P.3
Asikainen, J.4
Kokko, A.5
Rannio, T.6
-
81
-
-
84990922829
-
Norway to facilitate switch to biosimilars with 3m Remicade study
-
accessed 07.01.16
-
[81] BioPharma, Norway to facilitate switch to biosimilars with 3m Remicade study. http://www.biopharma-reporter.com/Markets-Regulations/Norway-to-facilitate-switch-to-biosimilars-with-3m-Remicade-study, 2013 accessed 07.01.16.
-
(2013)
-
-
BioPharma1
-
82
-
-
84929610400
-
Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization
-
[82] Danese, S., Fiorino, G., Michetti, P., Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization. J Crohns Colitis 8 (2014), 1548–1550.
-
(2014)
J Crohns Colitis
, vol.8
, pp. 1548-1550
-
-
Danese, S.1
Fiorino, G.2
Michetti, P.3
-
83
-
-
84897545473
-
The Portuguese Society of Rheumatology position paper on the use of biosimilars
-
[83] Fonseca, J.E., Gonçalves, J., Araújo, F., Cordeiro, I., Teixeira, F., Canhão, H., et al. The Portuguese Society of Rheumatology position paper on the use of biosimilars. Acta Reumatol Port 39 (2014), 60–71.
-
(2014)
Acta Reumatol Port
, vol.39
, pp. 60-71
-
-
Fonseca, J.E.1
Gonçalves, J.2
Araújo, F.3
Cordeiro, I.4
Teixeira, F.5
Canhão, H.6
-
84
-
-
84896273663
-
Biosimilar medicines – their use in the treatment of inflammatory bowel diseases. Position statement of the working group of the Polish National Consultant in Gastroenterology
-
[84] Mularczyk, A., Gonciarz, M., Bartnik, W., Durlik, M., Eder, P., Gąsiorowska, A., et al. Biosimilar medicines – their use in the treatment of inflammatory bowel diseases. Position statement of the working group of the Polish National Consultant in Gastroenterology. Prz Gastroenterol 9 (2014), 1–3.
-
(2014)
Prz Gastroenterol
, vol.9
, pp. 1-3
-
-
Mularczyk, A.1
Gonciarz, M.2
Bartnik, W.3
Durlik, M.4
Eder, P.5
Gąsiorowska, A.6
-
85
-
-
80054922640
-
NCCN Biosimilars white paper: regulatory, scientific, and patient safety perspectives
-
[85] Zelenetz, A.D., Ahmed, I., Braud, E.L., Cross, J.D., Davenport-Ennis, N., Dickinson, B.D., et al. NCCN Biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw 9:Suppl. 4 (2011), S1–S22.
-
(2011)
J Natl Compr Canc Netw
, vol.9
, pp. S1-S22
-
-
Zelenetz, A.D.1
Ahmed, I.2
Braud, E.L.3
Cross, J.D.4
Davenport-Ennis, N.5
Dickinson, B.D.6
-
86
-
-
84942303588
-
Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study
-
[86] Jahnsen, J., Detlie, T.E., Vatn, S., Ricanek, P., Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol 9:Suppl. 1 (2015), 45–52.
-
(2015)
Expert Rev Gastroenterol Hepatol
, vol.9
, pp. 45-52
-
-
Jahnsen, J.1
Detlie, T.E.2
Vatn, S.3
Ricanek, P.4
-
87
-
-
85020318416
-
Efficacy and safety of the Biosimilar Infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort
-
[Epub ahead of print]
-
[87] Gecse, K.B., Lovász, B.D., Farkas, K., Banai, J., Bene, L., Gasztonyi, B., et al. Efficacy and safety of the Biosimilar Infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohns Colitis, 2015 [Epub ahead of print].
-
(2015)
J Crohns Colitis
-
-
Gecse, K.B.1
Lovász, B.D.2
Farkas, K.3
Banai, J.4
Bene, L.5
Gasztonyi, B.6
-
88
-
-
84990994974
-
Biosimilars for prescribers
-
accessed 07.01.16
-
[88] GABI, Biosimilars for prescribers. 2015 http://gabi-journal.net/biosimilars-for-prescribers.html accessed 07.01.16.
-
(2015)
-
-
GABI1
-
89
-
-
84942256493
-
Biosimilars for the management of rheumatoid arthritis: economic considerations
-
[89] Gulácsi, L., Brodszky, V., Baji, P., Kim, H., Kim, S.Y., Cho, Y.Y., et al. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol 11:Suppl. 1 (2015), S43–S52.
-
(2015)
Expert Rev Clin Immunol
, vol.11
, pp. S43-S52
-
-
Gulácsi, L.1
Brodszky, V.2
Baji, P.3
Kim, H.4
Kim, S.Y.5
Cho, Y.Y.6
-
90
-
-
84941878057
-
®) for the treatment of autoimmune diseases in five European countries
-
®) for the treatment of autoimmune diseases in five European countries. Adv Ther 32 (2015), 742–756.
-
(2015)
Adv Ther
, vol.32
, pp. 742-756
-
-
Jha, A.1
Upton, A.2
Dunlop, W.C.3
Akehurst, R.4
-
91
-
-
84977863882
-
A budget impact model for biosimilar infliximab in Crohn's disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia
-
[91] Brodszky, V., Rencz, F., Péntek, M., Baji, P., Lakatos, P.L., Gulácsi, L., A budget impact model for biosimilar infliximab in Crohn's disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. Expert Rev Pharmacoecon Outcomes Res, 2015, 1–7.
-
(2015)
Expert Rev Pharmacoecon Outcomes Res
, pp. 1-7
-
-
Brodszky, V.1
Rencz, F.2
Péntek, M.3
Baji, P.4
Lakatos, P.L.5
Gulácsi, L.6
-
92
-
-
84942250284
-
5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany
-
Abstract number: 1166
-
[92] Kim, J.S., Hong, J.A., Kudrin, A., 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany. ACR/ARHP Annual meeting, 2014 Abstract number: 1166.
-
(2014)
ACR/ARHP Annual meeting
-
-
Kim, J.S.1
Hong, J.A.2
Kudrin, A.3
-
93
-
-
84904338227
-
Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries
-
[93] Brodszky, V., Baji, P., Balogh, O., Péntek, M., Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ 15:Suppl. 1 (2014), S65–S71.
-
(2014)
Eur J Health Econ
, vol.15
, pp. S65-S71
-
-
Brodszky, V.1
Baji, P.2
Balogh, O.3
Péntek, M.4
-
94
-
-
84944931026
-
Treatment preferences of originator vs. biosimilar drugs in Crohn's disease; discrete choice experiment among gastroenterologists
-
[94] Baji, P., Gulácsi, L., Lovász, B.D., Golovics, P.A., Brodszky, V., Péntek, M., et al. Treatment preferences of originator vs. biosimilar drugs in Crohn's disease; discrete choice experiment among gastroenterologists. Scand J Gastroenterol 51 (2016), 22–27.
-
(2016)
Scand J Gastroenterol
, vol.51
, pp. 22-27
-
-
Baji, P.1
Gulácsi, L.2
Lovász, B.D.3
Golovics, P.A.4
Brodszky, V.5
Péntek, M.6
-
95
-
-
84922747685
-
Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe
-
[95] Rencz, F., Péntek, M., Bortlik, M., Zagorowicz, E., Hlavaty, T., Śliwczyński, A., et al. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World J Gastroenterol 21 (2015), 1728–1737.
-
(2015)
World J Gastroenterol
, vol.21
, pp. 1728-1737
-
-
Rencz, F.1
Péntek, M.2
Bortlik, M.3
Zagorowicz, E.4
Hlavaty, T.5
Śliwczyński, A.6
-
96
-
-
84901926678
-
Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland
-
[96] McCarthy, G., Ebel, B.C., Guy, H., Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland. Value Health, 16, 2013, A558.
-
(2013)
Value Health
, vol.16
, pp. A558
-
-
McCarthy, G.1
Ebel, B.C.2
Guy, H.3
-
97
-
-
85027356080
-
Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
-
accessed 07.01.16
-
[97] NICE, Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. 2015 http://www.nice.org.uk/guidance/ta329/chapter/1-Guidance accessed 07.01.16.
-
(2015)
-
-
NICE1
-
98
-
-
85020777663
-
TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (including a review of TA143 and TA233)
-
accessed 07.01.16
-
[98] NICE, TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis (including a review of TA143 and TA233). 2015 http://www.nice.org.uk/guidance/GID-TAG355/documents/ankylosing-spondylitis-and-axial-spondyloarthritis-nonradiographic-adalimumab-etanercept-infliximab-and-golimumab-inc-rev-ta143-and-ta233-id694-final-appraisal-determination-document2 accessed 07.01.16.
-
(2015)
-
-
NICE1
|